Butalbital, Acetaminophen, and Caffeine
- Product NDC
- 45865-352
- 11-digit product format
- 458650352
- Labeler code
- 45865
- Product ID
- 45865-352_9701eac6-13dc-8c82-e053-2a95a90a10f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA200243
- Marketing category
- ANDA
- Marketing start
- 2012-09-13
- Marketing end
- 0000-00-00
- Substance
- BUTALBITAL; ACETAMINOPHEN; CAFFEINE
- Active strength
- 50 mg/1; mg/1; mg/1
- Pharmacologic classes
- Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45865-352-30 | Butalbital, Acetaminophen, and Caffeine | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
| 45865-352-60 | Butalbital, Acetaminophen, and Caffeine | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
| BUTALBITAL | ACTIVE INGREDIENT | KHS0AZ4JVK | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
| BUTALBITAL | ACTIVE MOIETY | KHS0AZ4JVK | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-352 | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS] | 2 | Legacy NDC, 2 package rows | 20191228_1d382246-ee7b-69cc-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45865-352-30 | 45865035230 | 30 TABLET in 1 BOTTLE, PLASTIC (45865-352-30) | 30 tablet | 2015-08-13 | 0000-00-00 | No | No | Current |
| 45865-352-60 | 45865035260 | 60 TABLET in 1 BOTTLE, PLASTIC (45865-352-60) | 60 tablet | 2015-08-13 | 0000-00-00 | No | No | Current |